A Single-Center, Clinical Study to Evaluate the Safety of a Non-Fragranced Personal Lubricant in Healthy Female Subjects

• Sponsor: Church & Dwight Company, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02320227
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Duration (Months): 1
• Patients Per Site Per Month: 29.5

Study Details

Study Description

Brief Summary

To evaluate the safety of a personal lubricant when used as indicated as a personal lubricant in the vagina and vulvar/perineal areas at least four times weekly for two weeks in a population of healthy females

Condition or Disease	Intervention/Treatment	Phase
Erythema; Edema	Device: Miami w/o frag Personal lubricant	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Study Start Date: Dec 1, 2014
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Miami w/o frag Personal lubricant Healthy subjects use Miami w/o frag Personal lubricant at least 4 times per week for 2 weeks	Device: Miami w/o frag Personal lubricant

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Observed Local Erythema [14 Days]

   Number of participants with observed local erythema by OB/GYN examination.

2. Number of Participants With Observed Local Edema [14 days]

   Number of participants with observed edema by OB/GYN examination.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subject is female between the ages of 18 and 49 years (at lease 21 subjects) or 50-60 years (no more than 9 subjects);

• Subject is using adequate non-barrier method of birth control [established us of hormonal methods of contraception (oral, injected, implanted, or patch), intrauterine device (IUD) or intrauterine system (IUS), surgical sterilization (e.g. in a monogamous relationship with male partner with vasectomy];

• Subject is free of any vaginal disorders;

• Subject is sexually active and in a monogamous, heterosexual relationship, and whose male partner is willing and able to give informed consent and agrees to engage in sexual intercourse at least twice each week during the two-week study (at least 50% and up to 100% of the study population) or is not sexually active (no more than 50% of the population);

• Subject is a personal lubricant user and agrees to replace her usual personal lubricant with the investigational product;

• Subject has normal menstrual cycle and is not expected to menstruate 2-4 days before or after the examination days;

• Subject agrees to use the provided investigational product at least four times weekly (including at least twice weekly during sexual intercourse for subjects with monogamous, male partners) over the two-week study period;

• Subject exhibits no clinically significant evidence of vulvar or vaginal irritation, as determined by a study doctor, and no reports of sensory irritation at the baseline examination;

• Subject is willing to refrain from introducing any new vaginal products, or using vaginal medication or local contraceptives (including condoms and hormonal rings), during the course of this study;

• Subject agrees to refrain from douching or using any medications, powder, lotions or personal care products in the vulvar or perianal area for the duration of the study (Note: subjects may continue to use their usual pantyliner, if any);

• Subject is willing to use a urine pregnancy test provided to them at baseline and on the third visit (Week 2, day 14);

• Subject has a standard Clinical Research Laboratories, Inc. (CRL) Medical History form on file at CRL and has completed study specific Medical History and Screener/Inclusion forms;

• Subject has signed and, if sexually active and in a monogamous relationship, whose partner has signed, an Informed Consent Form (ICF) in compliance with 21 CFR Part 50: "Protection of Human Subjects";

• Subject (and male partner, if applicable) has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164;

• Subject is dependable and able to follow directions as outlined in the protocol;

• Subject receives a score of 0 or 0.5 for erythema and edema, and 0 for sensorial irritation (burning, stinging, itching, and dryness) during the first examination.

Exclusion Criteria:

• Subject is pregnant, nursing, or planning a pregnancy;

• Subject is post-menopausal or has had a hysterectomy;

• Subject is currently using, or has used within two weeks prior to study initiation, any systemic or topical corticosteroids, vasoconstrictors, antibiotics, anti-inflammatories, or antihistamines;

• Subject has known allergies to vaginal or any cosmetic products (including lotions, moisturizer, powder, sprays, etc.);

• Subject reports a history of recurrent bladder, vaginal infection, or incontinence;

• Subject exhibits or reports gynecological abnormalities or has had vaginitis within 60 days prior to study initiation.

• Subject is expected to menstruate 2-4 days before or after the time of the first, second, and third examination;

• Subject uses a vaginal ring, diaphragm or cervical/vault caps, condoms, or condoms with spermicide as a means of contraception;

• Subject has participated in a study involving the vaginal area or in an investigational systemic drug study within two weeks of study initiation;

• Subject receives a score higher than 0.5 for erythema, edema, or >0 for burning, stinging, or itching, during the first examination or shows any other sign of mucosal irregularities (dryness, papules, vesticulation, fissure).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Laboratories	Piscataway	New Jersey	United States	08854

Sponsors and Collaborators

• Church & Dwight Company, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Church & Dwight Company, Inc.
• ClinicalTrials.gov Identifier: NCT02320227
• Other Study ID Numbers: ST-7557
• First Posted: Dec 19, 2014
• Last Update Posted: Mar 10, 2017
• Last Verified: Jan 1, 2017

• Additional relevant MeSH terms: Erythema

Study Results

Participant Flow

Arm/Group Title	Experimental: Healthy Subjects
Arm/Group Description	Novel Personal Lubricant Miami w/o Fragrance
Period Title: Overall Study
STARTED	30
COMPLETED	30
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Experimental: Healthy Subjects
Arm/Group Description	Novel Personal Lubricant Miami w/o Fragrance
Overall Participants	30
Age, Customized (participants) [Number]
Age 22-59	30 100%
Sex: Female, Male (Count of Participants)
Female	30 100%
Male	0 0%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Observed Local Erythema
Description	Number of participants with observed local erythema by OB/GYN examination.
Time Frame	14 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Miami w/o Frag Personal Lubricant
Arm/Group Description	Healthy subjects use Miami w/o frag Personal lubricant at least 4 times per week for 2 weeks
Measure Participants	30
Number [participants]	0 0%

2. Primary Outcome

Title	Number of Participants With Observed Local Edema
Description	Number of participants with observed edema by OB/GYN examination.
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Miami w/o Frag Personal Lubricant
Arm/Group Description	Healthy subjects use Miami w/o frag Personal lubricant at least 4 times per week for 2 weeks.
Measure Participants	30
Number [participants]	0 0%

Adverse Events

Arm/Group Title	Experimental: Healthy Subjects
Arm/Group Description	Novel Personal Lubricant Miami w/o Fragrance
All Cause Mortality
	Experimental: Healthy Subjects
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Experimental: Healthy Subjects
	Affected / at Risk (%)	# Events
Total	0/30 (0%)
Other (Not Including Serious) Adverse Events
	Experimental: Healthy Subjects
	Affected / at Risk (%)	# Events
Total	0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Master service agreement and confidentiality agreement in place